Effects of Xalatan

1
Effects of Xalatan (latanoprost) or Travatan
(travoprost) on Ocular Surface Signs and Symptoms
in Ocular Hypertensive or Glaucoma Patients.

• M.B. McDonald1, R.T. Sturm6, R.M. Caronia6, P.R.
  Galstian6, G. D'Aversa3, R.G. Fumuso2, E.D.
  Donnenfeld1, H.D. Perry2, J.R. Wittpenn, Jr.5,
  J.K. Oats5, M.A. Swerdin3, D.M. Sachs4, R.E.
  Mariani6.
• 1Ophthalmology, Ophthalmic Consultants of Long
  Island, Lynbrook and Rockville Centre, NY
  2Ophthalmology, Ophthalmic Consultants of Long
  Island, Rockville Centre, NY 3Ophthalmology,
  Ophthalmic Consultants of Long Island, Valley
  Stream, NY 4Ophthalmology, Ophthalmic
  Consultants of Long Island, East Meadow, NY
  5Ophthalmology, Ophthalmic Consultants of Long
  Island, Stony Brook, NY 6Ophthalmology,
  Ophthalmic Consultants of Long Island, Lynbrook,
  NY

The authors of this poster have received research
funding from Pfizer Inc.
2
Revised Abstract

• Purpose Burning and stinging associated
  prostaglandin instillation are associated with
  treatment failures due to non-compliance, it is
  worse in patients with dry eye. This pilot study
  examines potential differences in the ocular
  signs and symptoms in patients treated with
  either latanoprost or travoprost, based
  subjective and clinical assessments.
• Methods The study includes up to 40 patients
  (80 eyes) with ocular hypertension or glaucoma
  with mild to moderate dry eye (Grade 3, Oxford
  Grading Scale) enrolled to complete four visits
  over two months. Initially, screened patients are
  allowed 4-28 days to washout of their current
  medication after which patients are randomized to
  receive either drug (baseline). Patients follow
  treatment regimen until exit at day 56. Primary
  endpoint is the OSDI scores (patients subjective
  assessment) while secondary endpoints are
  clinical TBUT, corneal assessment, lissamine
  green staining, and slit-lamp exam. All
  evaluations are performed by a masked
  investigator. ANOVA was performed to compare
  treatment outcomes.
• Results At day 56, both treatments did not
  have a significant impact on OSDI when compared
  to baseline (p0.7 for travoprost and p0.9 for
  latanoprost, n5/group). TBUT remained unchanged
  for latanoprost (p0.9, n5), but was
  significantly lower than baseline after
  travoprost treatment (p0.04, n5). Tear flow
  remained statistically unchanged after travoprost
  (p0.2, n5) or latanoprost (p0.5, n5)
  treatment. BCVA after travoprost and latanoprost
  treatment was not affected (p0.9 for travoprost
  and p0.7 for latanoprost, n5/ group). Central
  corneal grading (p0.2, n5), lissamine staining
  (p0.6, n5) and slit lamp biomicroscopy (p0.4,
  n5) scores remained unchanged when compared to
  baseline. In an ongoing study, Travatan Z
  (travoprost) is also compared to latanoprost.
  Preliminary results indicate no significant
  differences in OSDI scores between treatment
  groups (pgt0.2, n4).
•  Conclusions In this interim report. travoprost
  or latanoprost treatments did not statistically
  change patients subjective assessment. The only
  statistically significant finding was after
  travoprost treatment, TBUT decreased (worsened)
  over the treatment period (p0.04, n5). Studies
  are currently ongoing to compare Travatan Z
  (travoprost) to latanoprost.
•  

3
Introduction

• Prostaglandins are a popular choice for treatment
  of ocular hypertension or glaucoma because of
  their clinical efficacy and once-daily dosing
  schedule.
• Unfortunately the burning and stinging associated
  with their instillation contributes to treatment
  failures due to non-compliance, which is worse in
  patients with dry eye.
• This pilot study examines potential differences
  in the ocular signs and symptoms in patients
  treated with either latanoprost or travoprost,
  based subjective and clinical assessments.

4
Methods

• This initial study was performed with 5 patients
  in each treatment group and is set to enroll 40
  patients (80 eyes).
• Patients with ocular hypertension or glaucoma
  with mild to moderate dry eye (Grade 3, Oxford
  Grading Scale) were enrolled to complete four
  visits over two months.
• At the 1st visit, screened patients are allowed
  4-28 days to washout of their current medication.
  
• The 2nd visit is the baseline where patients are
  randomized to receive either Xalatan
  (latanoprost ophthalmic solution) or Travatan
  (travoprost ophthalmic solution) .
• Patients follow treatment regimen until exit at
  day 56.
• Primary endpoint is the OSDI scores (patients
  subjective assessment).
• Secondary endpoints are clinical TBUT, corneal
  assessment, lissamine green staining, and
  slit-lamp exam.
• All evaluations are performed by a masked
  investigator.
• ANOVA was performed to compare treatment
  outcomes.

5
Results

• Both treatments had no statistically significant
  impact on OSDI scores.
• There were no significant differences in OSDI
  scores over the treatment period compared to
  baseline (p0.7 for Travatan and p0.9 for
  Xalatan, n5 per group).
• The lower the OSDI score the lower the dry eye
  related disease severity.

6
Results

(P0.04, n5)

• TBUT remained unchanged for Xalatan (p0.9,
  n5).
• On visit 4, TBUT was significantly lower than
  baseline after Travatan treatment (p0.04, n5).

7
Results

• Tear flow remained statistically unchanged after
  Travatan (p0.2, n5) or Xalatan (p0.5, n5)
  treatment over the treatment period.

8
Results

• BCVA was measured using the logMAR (minimum angle
  of resolution).
• BCVA after Travatan and Xalatan treatment was
  not affected (p0.9 for Travatan and p0.7 for
  Xalatan, n5 per group).

9
Results

• Secondary Evaluation Criteria
• After visit 4 (56 days after treatment with
  either Travatan or Xalatan), secondary
  evaluation criteria such as central corneal
  grading (p0.2, n5), lissamine staining (p0.6,
  n5) and slit lamp biomicroscopy (p0.4, n5)
  scores remained unchanged when compared to
  baseline.

10
Results

• In an ongoing study, Travatan Z is also compared
  to Xalatan.
• Preliminary OSDI scores measured at final patient
  visit (visit 4) indicate no statistically
  significant differences between treatment groups
  (pgt0.2, n4).
• The lower the OSDI score the lower the dry eye
  related disease severity.

11
Conclusions

• In this interim report, Travatan and Xalatan
  treatments, did not statistically change the
  patients subjective assessment.
• The only statistically significant finding was in
  the Travatan treatment group, where TBUT
  decreased (worsened) over the treatment period
  (p0.04, n5).
• Studies are currently ongoing to compare Travatan
  Z to Xalatan.